comparison of chemoradiotherapy and chemoradiotherapy combined with consolidation chemotherapy for escc

Conditions: Esophageal Squamous Cell Carcinoma; Chemotherapy Effect; Side Effect of Drug

Summary: this study is a phase iii, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. the survival time and side effects of patients were observed and compared.

test grouping: group a: radical chemoradiotherapy group; group b: radical chemoradiotherapy combined with consolidation chemotherapy group; specific chemotherapy regimens: concurrent chemotherapy (2 courses): lipusu (t) + cisplatin (ddp) scheme: t 135mg/m2 ivgtt, d1, 3week\*2cycles; ddp 75mg/m2 ivgtt, d2, 3week\*2cycles; consolidation chemotherapy (4 courses): after the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; radiotherapy scheme: intensity modulated radiotherapy ptv50-54gy, pgtv 56-60gy, conventional fractionation. primary efficacy endpoints: 3-year overall survival (os), 5-year overall survival (os) secondary efficacy endpoints: 3-year progression-free survival (pfs), 5-year progression-free survival (pfs), objective response rate (orr), disease control rate (dcr), toxic and side effects, and patient quality of life

Eligibility criteria:
inclusion criteria: 1. age 18-70 years old, not limited to male or female; at least able to take liquid diet; 2. esophageal squamous cell carcinoma proved by histopathology; 3. esophageal squamous cell carcinoma that is inoperable or refuses surgery, 4. according to the 2017 8th edition of ajcc esophageal cancer new staging criteria, the tumor is t2n0m0-txnxm0 stage; 5. ecog 0-1; life expectancy \> 6 months; 6. no chemotherapy was used before selection; 7. no history of radiotherapy; 8. no surgical treatment; 9. no serious allergic history; 10. hemoglobin 100 g/l, wbc3.5109/l, neutrophils 1.5109, platelets 100109/l; cr1.5 upper limit of normal, tb2.5 upper limit of normal, ast and alt2.5 upper normal limit, akp2.5 upper normal limit ; be able to understand the research and have signed the informed consent; exclusion criteria: 1. history of malignant tumors in other parts; 2. duplicate carcinoma of the esophagus; 3. pregnant or lactating patients; 4. fertility but not using contraceptive measures; 5. serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade ii, mental history and severe diabetes; 6. during the active period of infectious diseases; 7. participate in other clinical trials at present or within four weeks before enrollment; 8. simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional chinese medicine); 9. after esophageal stent placement; 10. cases with perforation tendency; 11. have a history of organ transplantation. 12. widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases; 13. known or suspected allergic to chemotherapy drugs; according to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.